Comparing the efficacy of two local anaesthetic agents (levobupivacaine and ropivacaine) with routinely used bupivacaine local anaesthetic for cesarean delivery by spinal anaesthesia.

Completed

• Conditions: Obstetrics,

• Registration Number: CTRI/2020/12/030163
• Lead Sponsor: Malankara Orthodox Syrian Church Medical College

Brief Summary

**Abstract**

**Background**: Spinal anaesthesia is a popular technique for caesarean section. Our study was designedto determine the efficacy and safety of newer local anaesthetics, Levobupivacaine and Ropivacaine andcompare it with commonly used Hyperbaric Bupivacaine for spinal anaesthesia in elective caesareansection.

**Method**: In this prospective, randomized controlled, double-blind study, 90 parturients were allocatedto three groups of 30 each. Group A (control) received 0.5% Hyperbaric Bupivacaine 1.8ml with 25mcgFentanyl, Group B (study) received 0.5% Levobupivacaine 1.8ml with 25mcg with Fentanyl, Group C(study) received 0.75% Ropivacaine 1.8ml with 25mcg Fentanyl. The study drug was consideredeffective if an upper sensory level of T6 or above was achieved and if intraoperative supplementationwas not required for successful completion of surgery. Parturients hemodynamic parameters, sensory,motor characteristics and complications as well as neonatal safety were assessed.

**Results:** Anaesthesia was effective in 96.7% of parturients in A and C groups and 80% in B group.Duration of motor block was shorter in B (112.83±21.57mins P=.000) and C (122.06±19.84mins P=.016)groups compared to A group (136.96±18.87mins). Mean duration of analgesia was lesser in B(208.33±44.54mins, P=.001) and C (218.62±21.91mins, P=.010) groups when compared to A(245.96±35.99mins). Episodes of intraoperative hypotension and the amount of Ephedrine consumedwere higher in C group compared to group A (P=0.039). Maternal and neonatal outcomes weresatisfactory in all the three groups.

**Conclusion:** Ropivacaine 0.75% was as efficacious as Hyperbaric Bupivacaine 0.5% in providingsatisfactory spinal anaesthesia for caesarean section. Levobupivacaine 0.5% was found to be inferior toBupivacaine and Ropivacaine in terms of efficacy. Duration of analgesia and duration of motor blockadewas shorter with Levobupivacaine and Ropivacaine when compared to Bupivacaine. Maternal andneonatal safety were ensured in all the three groups.



Keywords: *Bupivacaine; Levobupivacaine; Ropivacaine; Fentanyl; spinal anaesthesia; caesarean section.*

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-28
• Study Completion: 2014-09-12
• Last Update Posted: 2020-12-18

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• ASA 1 Parturient 2.
• Height 145-175cms 3.
• Singleton term pregnancy 4.
• Elective caesarean section.

Exclusion Criteria

• Parturient refusal 2.
• Local infection 3.
• Coagulopathy 4.
• Allergy to the study drugs 5.
• Any neurological deficit 6.
• Multifoetal gestation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neonatal outcome	1. Sensory assessment: every 2 min from 2 to 20 min and then every 10min until recovery to T12 | 2. Motor assessment: at baseline, then 2, 4, 6, 10, 15, and 20 mins after intrathecal injection and as soon as possible at the end of surgery. Every 10min after surgery. | 3. Hemodynamics: at 2-minute intervals for 20 mins and 10 mins interval throughout the surgery and one-hour interval up to six hours postoperatively
comaprison of sensory, motor charactersitics of the study drug	1. Sensory assessment: every 2 min from 2 to 20 min and then every 10min until recovery to T12 | 2. Motor assessment: at baseline, then 2, 4, 6, 10, 15, and 20 mins after intrathecal injection and as soon as possible at the end of surgery. Every 10min after surgery. | 3. Hemodynamics: at 2-minute intervals for 20 mins and 10 mins interval throughout the surgery and one-hour interval up to six hours postoperatively
Anesthetic efficacy of study drugs	1. Sensory assessment: every 2 min from 2 to 20 min and then every 10min until recovery to T12 | 2. Motor assessment: at baseline, then 2, 4, 6, 10, 15, and 20 mins after intrathecal injection and as soon as possible at the end of surgery. Every 10min after surgery. | 3. Hemodynamics: at 2-minute intervals for 20 mins and 10 mins interval throughout the surgery and one-hour interval up to six hours postoperatively
complications	1. Sensory assessment: every 2 min from 2 to 20 min and then every 10min until recovery to T12 | 2. Motor assessment: at baseline, then 2, 4, 6, 10, 15, and 20 mins after intrathecal injection and as soon as possible at the end of surgery. Every 10min after surgery. | 3. Hemodynamics: at 2-minute intervals for 20 mins and 10 mins interval throughout the surgery and one-hour interval up to six hours postoperatively

Secondary Outcome Measures

Name	Time	Method
SEVERITY OF COMPLICATION	DURING FIRST 20MINUTES AFTER THE SPINAL ANESTHESIA

Trial Locations

Locations (1)

Malankara Orthodox Syrian Church Medical College; 🇮🇳 Ernakulam, KERALA, India

Malankara Orthodox Syrian Church Medical College

🇮🇳Ernakulam, KERALA, India

Dr Melwin George

Principal investigator

9995238342

drmelwing@gmail.com